First-in-human, open label, Phase I/IIa clinical trial using ULSCs to treat patients with Acute Respiratory Distress Syndrome (ARDS) resulting from COVID19 infection. This study has completed enrollment for the first 20 patients in the Phase I phase. This study was established as a collaborative effort with multiple institutions participating, including Baptist Health, Miami, Florida and Sanford Health, Sioux Falls, South Dakota and RESTEM.
ARDS is respiratory failure that occurs when air sacks within the lungs fill with fluid. This fluid prevents lungs from filling with adequate oxygen, which decreases oxygen in the bloodstream. Decreased oxygen in the bloodstream limits the amount of oxygen reaching organs responsible for essential bodily functions, causing organ failure. ARDS typically develops in patients with other severe illnesses, such as COVID19. Currently, there is no FDA approved therapy to treat patients with this fatal condition.
The Phase II phase will evaluate the use of ULSCs in patients with post COVID symptoms, which goes by several names including Long COVID, Long Haulers and Post Acute COVID Syndrome (PACS). This condition is associated with persistent symptoms occurring weeks or months after initial infection. Symptoms include heart inflammation, shortness of breath, fatigue, and brain fog. While severity varies between individuals, Long Covid can cause extreme deterioration of health, wellbeing, and overall quality of life.
To learn more about this trial, visit: Umbilical Cord Lining Stem Cells (ULSC) in Patients With COVID-19 ARDS – Full Text View – ClinicalTrials.gov
To read the Press Release of this trial, visit: FDA approves COVID-19 trial after successful emergency use of umbilical stem cells from RESTEM (prnewswire.com)
If you are interested in learning more or getting involved, please contact us.